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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K863491
Device Name BLOOD SPECIMEN COLLECTION DEVICES
Applicant
Medelec Intl. Corp.
One Lincoln Rd., Suite 304
Miami Beach,  FL  33139
Applicant Contact DOCAL, M.D.
Correspondent
Medelec Intl. Corp.
One Lincoln Rd., Suite 304
Miami Beach,  FL  33139
Correspondent Contact DOCAL, M.D.
Regulation Number862.1675
Classification Product Code
JKA  
Date Received09/08/1986
Decision Date 10/24/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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